It is known that mineral substances and trace elements are of vital importance in the human (generally in living) organism(s). A great number of publications deal with the effect of the given elements (such as zinc, potassium, magnesium and phosphorus) applied separately.
The idea of the "milieu interieur" created by Claude Bernard in last century is also known. According to Dr. Bernard the main condition of free and independent life is the stability in the interior milieu. The mechanism ensuring the permanence in the "interior milieu" is very important for life. The question of "milieu interieur" is still under dispute, however, it is accepted by every scientist that the extracellular and intracellular ion concentrations are a part of it.
The second main thermodinamical law is an universal rule, so it must be valid in case of living organisms as well.
Living organisms (living cells) do not seem to come under this rule as they keep themselves at an energy level higher than that of their environment. Of course this is just a semblance, the cells are unable to uphold this higher energy level on the long run, that is why they get old, sick and die.
Having studied numerous publications I came to the recognition that in old or sick cells the concentration of adenosine triphosphate (ATP), carrying the biological energy is decreasing, or at least the maximal amount of ATP which can be formed during a certain period of time is lower, thus the maximal efficiency of the cell is decreased. In close connection with this fact the intracellular ion concentration of the patient is changed, which can be both cause and effect. The trend of this change in the ion concentration can be predicted in a high probably (surely because of the fact that some ions are kept within the cell and others are kept off the cytoplasm by consuming biological energy, mainly ATP).
The original ion milieu seems to be optimal, any change in it exerts a negative effect on the cellular metabolism, and consequently on ATP production as well, which results in a further damage in the ion milieu of the cell, thus a particular self-inducing circle is developed.
As a rule this process does not go the end, i.e. to necrocytosis, but the metabolism and the ion milieu of the cell usually are stabilized at a lower level. This is valid, first of all, for the actually sick groups, tissues or organs, but it can be followed by secondary and tertiary alterations and the defensive mechanisms of the organism may simultaneously be activated.
I found that in the sick cells the concentration of the following ions tend to increase: sodium, calcium, hydrogen, chloride and copper. At the same time the concentration of the following ions probably decreases in the sick cells: potassium, magnesium, zinc, monohydrophosphate and dihydrophoshpate.
This whole concept is just a hypothesis, since the existence of ion pumps, working with biological energy (ATP) is proved and accepted only in case of three of the above ions (sodium, potassium and calcium). As to the rest of the ions the data available are few (as to di- and monohydrophosphate ions) or contradictory (as to zinc ion), or there are no data at all (as to chloride, hydrogen or Cu ions), or they support an opposite view (e.g. in the case of magnesium ions an active transport in the opposite direction is supposed, [see Hoang, N. D.: Magnesium Bulleting, 11 159-165 (1989)]. However, the reality of my concept is proved by good results of the clinical experiments.
Several works have recently been published regarding the physiological and pathological effect of magnesium and zinc. Rasmussen H. S. [Clin. Cardiol. 11 377-381 (1988)] applied with success magnesium salts in the form of i.v. infusions in a dose above the physiological level for treating acute myocardial infraction. Others have used magnesium salt i.v. in a dose close to the toxical level for treating arrhythmia [Iseri, L. T. et al: Magnesium 8, 299-306 (1989)].
Rasmussen, H. S. et al [Clin. Cardiol. 11 377-381 (1988)] have found that the i.v. application of magnesium in large doses has a long-lasting positive effect. This is due to the fact, I think, that magnesium had a normalizing effect on the sick cells, i.e. it promoted regeneration. Probably this is also an ion supplementation, however, it could be (partially) achieved only with very large serum doses.
Other researchers consider the use of magnesium in a physiological dose to be favourable, e.g. in case of hypertonia (magnesium aspartate containing 200 mg of magnesium daily). In this dose the results are moderate or even doubtful. It is generally accepted at the same time, that the majority of the civilized nations is underfed with magnesium, thus the application of magnesium product is not harmful, but definitely desirable also for healthy people.
As regards zinc the experiences are similar. It has been used as dermacological agent for centuries, however, it met real success only after its new discovery [Prasad, A. S. et al: J. Lab. Clin. Med. 61, 537-549 (1963)]. This had been preceded by the publication of Vallee's standard work about the per os use of zinc for treating liver cirrhosis [Vallee, B. L.: N. Engl. J. Med. 257, 1055-1065 (1957)].
Although zinc is used nowadays for treating 25 difference diseases in a dose exceeding the physiological level 6-8 times, its use is not widespread in medical practice.
The lack of potassium caused by diuretics and other agents is generally known and accepted, just like the fact that this lack must be ceased. It is believed that the lack of pottasium caused by insufficient nourishment is rare.
In medical literature the lack of phosphate ions is deemed to be very rare. Some monographs [e.g. Knochel J. P.: Arch. Int. Med. 137, 203-220 (1977)] mention more than a hundred articles, which prove the lack of phosphate ion and the importance of hypophosphatemia in connection with completely different diseases. Knochel, J. P. mentions that the lack of magnesium, potassium and phosphate ions occurs in many cases simultaneously. He mentions later, that hypophosphatemia and the deficiency in phosphorus are rare conditions and are even more rare to be cured. [N. Eng. J. Med. Chem. 313, 447-449 (1985)].
Practically there are no prior art references concerning intracellularphosphorus deficiency. Therefore it has become a common view among practitioners that the only thing to be mentioned about phosphate ion is that we eat too much of it, thus we can speak about phosphate overfeedig (and not underfeeding) [see Selye H.: Amer. Heart H.: 55, 805-809 (1958) and Proc. Soc. Exp. Biol. Med. 98 580-583 (1958)]. And this can lead to the breakdown of the ion balance, which may cause diseases (Seelig, M.: Amer. J. Cardio. 63: 4G-21G, 1989).
Contrary to what was thought, I have found in my investigations that in spite of the sufficient or excessive phosphate intake the occurrence of the intracellular phosphate ion lack is similar to that of the intracellular magnesium lack. This is probably due to metabolic and energetic reasons. Consequently, any dose of phosphate ions is (or would be) added, the intracellular stability cannot be restored unless magnesium, potassium and zinc are also applied simultaneously. Thus we can improve the cellular metabolism and the ATP production (since this will finally lead to the normalization of the ion concentration).
The exclusive application of phosphate ions in an overdose damages the organism also because it may bind magnesium and zinc in the intestines by forming hardly soluble precipitates, and thus causing lack of said elements and developing diseases.
The aim of the invention is to produce a pharmaceutical composition comprising a combination of magnesium, zinc, phosphorus and potassium for regenerating cells. In most cases the effect of this composition on the sick organism is favourable (better than that of using the elements separately), and there are practically no side effects.
The invention is based on the recognition that if the appropriate magnesium, potassium and zinc supply is ensured, then the phosphorous ions do not hinder but promote the effect of these elements. Applying these elements simultaneously the effect is considerably better than applying any of them separately.
Consequently, the effect of a composition comprising Mg, Zn and K ions can be improved considerably by adding a mixture of HPO.sub.4.sup.2- /H.sub.2 PO.sub.4.sup.- salts in an appropriate amount.
The invention is based on the recognition that a pharmaceutical composition containing zinc, magnesium, phosphorus and potassium in a certain ratio is effective for regenerating living cells. It could not be expected from the prior art that such a mixture produces a significant synergistic effect.